Division Chapter II Presentation of particulars and documents

The dossier of safety tests shall include the following:

• an index of all studies included in the dossier,

• a statement confirming that all data known by the applicant at the time of submission, whether favourable or unfavourable, are included,

• a justification for the omission of any type of study,

• an explanation of the inclusion of an alternative type of study,

• a discussion of the contribution that any study that pre-dates studies performed in line with good laboratory practice (GLP) according to Directive 2004/10/EC can make to the overall risk assessment.

Each study report shall include:

• a copy of the study plan (protocol),

• a statement of compliance with good laboratory practice, where applicable,

• a description of the methods, apparatus and materials used,

• a description and justification of the test system,

• a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,

• a statistical analysis of the results where appropriate,

• a discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings,

• a detailed description and a thorough discussion of the results of the study of the safety profile of the active substance, and its relevance for the evaluation of potential risks presented by residues to humans.